Cargando…

Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)

BACKGROUND: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is...

Descripción completa

Detalles Bibliográficos
Autores principales: Haun, Markus W., Tönnies, Justus, Krisam, Regina, Kronsteiner, Dorothea, Wensing, Michel, Szecsenyi, Joachim, Vomhof, Markus, Icks, Andrea, Wild, Beate, Hartmann, Mechthild, Friederich, Hans-Christoph
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8097128/
https://www.ncbi.nlm.nih.gov/pubmed/33952313
http://dx.doi.org/10.1186/s13063-021-05289-3
_version_ 1783688291813425152
author Haun, Markus W.
Tönnies, Justus
Krisam, Regina
Kronsteiner, Dorothea
Wensing, Michel
Szecsenyi, Joachim
Vomhof, Markus
Icks, Andrea
Wild, Beate
Hartmann, Mechthild
Friederich, Hans-Christoph
author_facet Haun, Markus W.
Tönnies, Justus
Krisam, Regina
Kronsteiner, Dorothea
Wensing, Michel
Szecsenyi, Joachim
Vomhof, Markus
Icks, Andrea
Wild, Beate
Hartmann, Mechthild
Friederich, Hans-Christoph
author_sort Haun, Markus W.
collection PubMed
description BACKGROUND: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients’ reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. METHODS: In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. DISCUSSION: To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. TRIAL REGISTRATION: ClinicalTrials.gov, United States National Institutes of Health NCT04316572. Prospectively registered on 20 March 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05289-3.
format Online
Article
Text
id pubmed-8097128
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-80971282021-05-05 Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial) Haun, Markus W. Tönnies, Justus Krisam, Regina Kronsteiner, Dorothea Wensing, Michel Szecsenyi, Joachim Vomhof, Markus Icks, Andrea Wild, Beate Hartmann, Mechthild Friederich, Hans-Christoph Trials Study Protocol BACKGROUND: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients’ reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. METHODS: In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. DISCUSSION: To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. TRIAL REGISTRATION: ClinicalTrials.gov, United States National Institutes of Health NCT04316572. Prospectively registered on 20 March 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05289-3. BioMed Central 2021-05-05 /pmc/articles/PMC8097128/ /pubmed/33952313 http://dx.doi.org/10.1186/s13063-021-05289-3 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Haun, Markus W.
Tönnies, Justus
Krisam, Regina
Kronsteiner, Dorothea
Wensing, Michel
Szecsenyi, Joachim
Vomhof, Markus
Icks, Andrea
Wild, Beate
Hartmann, Mechthild
Friederich, Hans-Christoph
Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
title Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
title_full Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
title_fullStr Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
title_full_unstemmed Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
title_short Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
title_sort mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the provide-c trial)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8097128/
https://www.ncbi.nlm.nih.gov/pubmed/33952313
http://dx.doi.org/10.1186/s13063-021-05289-3
work_keys_str_mv AT haunmarkusw mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT tonniesjustus mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT krisamregina mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT kronsteinerdorothea mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT wensingmichel mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT szecsenyijoachim mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT vomhofmarkus mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT icksandrea mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT wildbeate mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT hartmannmechthild mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial
AT friederichhanschristoph mentalhealthspecialistvideoconsultationsversustreatmentasusualinpatientswithdepressionoranxietydisordersinprimarycarestudyprotocolforanindividuallyrandomisedsuperioritytrialtheprovidectrial